Phase III trials of TMC 435 (Medivir/Tibotec) show positive response in patients with Hepatitis C
Top-line results from three pivotal Phase III trials examining TMC 435 (simeprevir, from Medivir/Tibotec, administered with pegylated interferon and ribavirin found that 80% and 81% of treatment-naive patients with chronic genotype 1 Hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). These results were from QUEST-1 and QUEST-2 trials. Results from the PROMISE trial found that 79% of prior relapsed patients treated with simeprevir achieved SVR12. All three studies utilized response-guided treatment (RGT) criteria and 85%, 91% and 93 % of the patients, respectively, were eligible to stop all treatments after 24 weeks.
The overall safety, tolerability and efficacy results from these studies were consistent with those previously obtained in phase II studies. Final analysis of the phase III trials is ongoing and the full data set from these studies will be submitted for presentation at future scientific conferences.
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